VYAIRE MEDICAL, INC PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE
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Model Number REVEL VENTILATOR |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problems
Hyperventilation (1910); Low Oxygen Saturation (2477)
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Event Date 12/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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Any additional information provided by the customer will be included in a follow up report.A vyaire certified service technician was unable to verify the customer¿s reported issue.The device passed 98.3 hours of extended bench testing, passed initial final test and initial alarm volume test with no abnormalities or alarm conditions.A review of the event trace indicates that the ¿blower demand exceeded alarm¿ condition was preceded by alarm conditions that indicates the presence of a significant patient circuit leak.These preceding alarm conditions include "low ve alarm", "low ppeak alarm", ¿patient circuit fault alarm¿, "low peep alarm" and "high breath rate alarm" which repeatedly trigger then recover along with the "blower demand exceeded alarm" condition.The presence of a patient circuit leak in excess of the 30lpm leak compensation capabilities of the ptv ventilator can result in continuous peak blower operation while the ventilator attempts to meet the breath requirement settings of the patient.The device passed all testing and met all vyaire manufacturer specifications.
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Event Description
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It was reported to vyaire that the revel ventilator displayed a blower motor alarm while connected to a patient.The customer stated that the patient's oxygen saturation dropped but there were several other factors that potentially played into that.The patient was on bilevel positive airway pressure (bipap) with the low pressure settings utilized by the transport crew.The customer stated that the patient was also very tachypneic.At this time, no further information has been provided regarding the patient's condition.
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